Fear of the Common Good and the Neglect of Justice

This chapter traces the practical and conceptual origins of eight problematic commitments including the perception that there is an inherent moral dilemma at the heart of research with humans and the tendency to conceptualize research as a private transaction between researchers and participants without clear connections to the requirements of a just social order. It introduces readers who are new to research ethics to key cases and documents relating to domestic and international research and illustrates how they gave rise to the problematic views that produce conceptual and practical tensions in the field. The chapter frames the questions that will be addressed in subsequent chapters, including issues about research risk; the role of paternalism in research ethics; and requirements relating to responsiveness to host community health needs, the standard of care, and post-trial access in international research.

Avoiding Justice: Research at the Auction Block

Although the principle of justice plays a peripheral role in domestic research in high-income countries, it grounds a series of requirements in international research relating to responsiveness to host community health needs, the standard of care, and assurances of post-trial access. This chapter reviews a proposal to eliminate what is seen as a cumbersome mix of requirements on international research in favor of a framework of procedures that render considerations of fairness more manageable within the confines of orthodox research ethics. This might appear to be an alternative to the approach defended in this book because it would avoid having to engage with difficult issues of justice that reach beyond the confines of the field as it is currently configured. This chapter argues that efforts to avoid substantive conceptions of justice wind up tacitly enforcing a particular conception of justice, and it is shown that the proposal to streamline the ethics of international research cannot satisfy some of the requirements that its proponents advocate.

Justice and the Human Development Approach to International Research

This chapter articulates and defends the human development approach to international research. This approach extends into the international context the egalitarian research imperative outlined in chapter 4, the integrative approach to research risk in chapter 6, and the non-paternalistic approach to research oversight in chapter 7. In this approach, requirements related to responsiveness to host community health needs, the standard of care, and post-trial access to study interventions are grounded in requirements of justice and the egalitarian research imperative. The result is a unified foundation for both domestic and international research ethics that treats research as a social undertaking, recognizes justice as the first virtue of social institutions, and gives moral force to the imperative to generate the information needed to improve the ability of social institutions to advance the common good.

Process Evaluation of MAPS: A Highly Tailored Digital Intervention to Support Medication Adherence in Primary Care Setting

Background: Medication adherence can prevent health risks, but many patients do not adhere to their prescribed treatment. Our recent trial found that a digital intervention was effective at improving medication adherence in non-adherent patients with Hypertension or Type 2 Diabetes; but we do not know how it brought about behavioural changes. This research is a post-trial process evaluation of the mechanism by which the intervention achieved its intended effects.Methods: A mixed methods design with quantitative and qualitative evidence synthesis was employed. Data was generated by two studies. Study 1 used questionnaires to measure the underlying mechanisms of and the medication adherence behaviour, and digital logfiles to objectively capture intervention effects on the process of behaviour change. Multilevel regression analysis on 57 complete intervention group cases tested the effects of the intervention at modifying the mechanism of behaviour change and in turn at improving medication adherence. Study 2 used in depth interviews with a subsample of 20 intervention patients, and eight practise nurses. Thematic analysis provided evidence about the overarching intervention functions and recommendations to improve intervention reach and impact in primary care.Results: Study 1 found that intervention effectiveness was significantly associated with positive changes in the underlying mechanisms of behaviour change (R2 = 0.26, SE = 0.98, P = 0.00); and this effect was heightened twofold when the tailored intervention content and reporting on medication taking (R2 = 0.59, SE = 0.74, P = 0.00) was interested into the regression model. Study 2 suggested that the intervention supported motivation and ability to adherence, although clinically meaningful effects would require very brief medication adherence risk appraisal and signposting to ongoing digitally delivered behavioural support during clinical consultations.Conclusion: This post trial process evaluation used objective methods to capture the intervention effect on the mechanisms of behaviour change to explain intervention effectiveness, and subjective accounts to explore the circumstances under which these effects were achieved. The results of this process evaluation will inform a large scale randomised controlled trial in primary care.

Efek terapi oksigen hiperbarik terhadap nilai Montreal Cognitive Assesment Indonesia (MoCA-INA) pada pasien cedera otak traumatik ringan

Hyperbaric oxygen therapy (HBOT) uses 100% oxygen at a pressure of more than 1 ATM in a chamber, therefore, it can improve the state of tissue hypoxia. This study was aimed to prove that TOHB could increase the MoCA-INA score in mild traumatic brain injury (mTBI). This study was carried out at the Surgery Department of Prof. Dr. R. D. Kandou Hospital, Manado using the pre and post trial design. Subjects were 20 patients with mTBI divided into two groups: treated with HBOT and control group (without HBOT). Each patient involved would be examined for MoCA-INA before and after treatment or with HBOT added. The results showed that before treatment, the MoCA-INA scores tended to be evenly distributed around 36 (SD 5). The score increased to 71 (SD 10) at post-injury management or a mean increase of 35 points (p<0.001 in the paired two-sample t-test). However, there was no significat difference in MoCA-INA scores between the first and the second measurements. The density of the two groups clearly overlapped even though the variation of MoCA-INA scores of the HBOT group was much wider than that of the control group (p=0.302 and 0.297 in the first and second measurements, respectively). There was no cognitive disturbance either mild, moderate, or severe in all patients. In conclusion, there was an increase of the MoCA-INA value in mTBI patients after treatment. The patients treated with HBOT showed wider variation of MoCA-INA score of pre and post HBOT than those without HBOT Keywords: HBOT; mTBI; MoCA-INA; cognitive function Abstrak: Terapi oksigen hiperbarik (TOHB) menggunakan oksigen 100% pada tekanan lebih dari 1 ATM dalam sebuah chamber sehingga dapat memperbaiki keadaan hipoksia jaringan. Penelitian ini bertujuan untuk membuktikan bahwa TOHB dapat meningkatkan nilai MoCA-INA pada pasien cedera otak traumatik ringan (COTr). Penelitian dilaksanakan di Bagian Bedah RSUP Prof. Dr. R. D. Kandou, Manado dengan menggunakan pre and posttrial design. Subyek penelitian ialah 20 pasien COTr dibagi dalam dua kelompok: dengan dan tanpa TOHB (kelompok kontrol). Setiap subyek diperiksa MoCA-INA sebelum dan sesudah penatalaksanaan cedera/disertai TOHB. Sebelum penatalaksanaan cedera, rerata skor MoCA-INA sekitar 36 (SD 5) dan nilai tersebut meningkat menjadi 71 (SD 10) pasca penatalaksanaan cedera atau kenaikan rerata 35 poin (p<0,001 pada uji t dua sampel berpasangan). Tidak tampak perbedaan skor MoCA-INA baik pada pengukuran pertama maupun kedua. Densitas kedua kelompok terlihat jelas tumpang tindih sekalipun variasi skor MoCA-INA group TOHB jauh lebih lebar daripada group kontrol (p=0,302 dan 0,297 masing-masing pada pengukuran pertama dan kedua). Tidak terlihat adanya gangguan kognitif ringan sedang maupun berat pada semua pasien. Simpulan penelitian ini ialah terdapat peningkatan nilai MoCA-INA pada pasien COTr. Pasien dengan TOHB memperlihatkan variasi skor MoCA-INA yang lebih besar pada pre dan pasca TOHB.Kata kunci: TOHB; COT; MoCA-INA; gangguan kognitif

Associations Between Endogenous Estrogen, Postmenopausal Hormone Therapy, and Cognitive Changes in Older Women

How markers of brain health are associated with endogenous estrogen and use of postmenopausal hormone therapy (HT) varies depending on women’s years from menopause and metabolic health status, ranging from potential benefit to harm. The Women’s Health Initiative (WHI) included 7,233 women age 65-80 who underwent a randomized clinical trial of various HT preparations for an average of 5.9 years. Over up to 18 years of post-trial follow-up, diabetes (DM2) increased the risk of dementia (hazard ratio [HR] 1.54 [95% CI 1.16–2.06]). Having DM2 and also treatment with unopposed conjugated equine estrogens increased the risk to HR=2.12 [1.47-3.06]. We hypothesize that the metabolic effects of estrogen in the brain drives this interaction. In support of this, the metabolic transition following menopause may alter the impact of other treatments on cognition, for example behavioral weight loss therapy to treat obesity in women with type 2 diabetes (interaction p=0.02 for executive function).

Eight-year post-trial follow-up of morbidity and mortality of telephone health coaching

Background Health coaching is a patient-centred approach to supporting self-management for the chronic conditions. However, long-term evidence of effectiveness of health coaching remains scarce. The object of this study was to evaluate the long-term effect of telephone health coaching (THC) on mortality and morbidity among people with type 2 diabetes (T2D), coronary artery disease (CAD) and congestive heart failure (CHF).. Methods 1535 T2D, CAD and CHF patients with unmet treatment targets were randomly allocated into an intervention group (n = 1034) and control group (n = 501). Intervention group received monthly individual strength-based, autonomy supportive THC sessions (average 30 min) for behavior change with a specially trained nurse for 12 months additional to usual health care. Control group received usual health care services. The primary outcome was a composite of death from cardiovascular causes or non-fatal stroke or non-fatal myocardial infarction (AMI) or unstable angina pectoris (UAP) during a follow-up of 8 years Three other composite endpoints with distinct combinations of fatal and non-fatal cardiovascular events and death from any cause were used as secondary outcomes. Other outcomes followed were the most relevant components of the composite endpoints. Randomized controlled trial (RCT) data was linked to Finnish national health and social care registries and electronic health records (EHR). Post-trial eight-year evaluation was conducted using intention-to-treat (ITT) and per-protocol (PP) analysis. Results The composite primary outcome event rate per 100 person years was lower in the intervention group (3.45) than in control group (3.88) in ITT -analysis, but the difference was not statistically significant (hazard ratio in the intervention group 0.87; 95% CI, 0.71 to 1.07; P = 0.19). In the subgroup (T2D, CAD/CHF) analysis, there were no statistically significant effects. The secondary PP-analysis showed statistically significant benefits for those who participated in the study. Conclusions No statistically significant effect of health coaching on mortality and morbidity was found in intention to treat analysis. The per protocol results suggest, however, that the intervention may be effective among patients who are willing and able to participate in health coaching. More research is needed to identify patients most likely to benefit from low-intensity health coaching. Trial registration NCT00552903 (registration date: the 1st of November 2007, updated the 3rd of February 2009).

Effect of short-term psychological intervention on anxiety of pregnant women with positive screening results for chromosomal disorders: a randomized controlled trial

Background and aim Prenatal diagnosis of fetal abnormalities is a critical and stressful event for women. Most pregnant women are concerned about fetal abnormalities and screening tests. Due to the importance of anxiety reduction in pregnant women, this study was conducted to determine the effect of short-term psychological intervention on the anxiety of pregnant women with positive screening results for chromosomal disorders. Methods A randomized clinical trial was performed on women referred to Akbarabadi Hospital in Tehran, Iran, who had positive screening results for chromosomal abnormalities. Participants were selected from eligible individuals by a continuous method and were assigned to two groups of cognitive-behavioral training (n = 46) and control (n = 46), using the block balanced randomization method. Participants in the cognitive-behavioral training group received 4 sessions of individual counseling. The control group received routine pregnancy visits. The Spielberger State-Trait Anxiety Inventory was completed before the intervention and immediately at the end of the intervention (before receiving the amniocentesis result). The analysis of intervention effects was performed as intention-to-treat and per-protocol analysis. Results There was a statistically significant difference in post-intervention state anxiety scores and trait anxiety scores (p < 0.001) between the intervention and control groups, when their means were adjusted for pre-intervention scores for both intention-to-treat and per-protocol analysis. Also, there was a large effect size between the groups in terms of state (ITT: ηp2 = 0.63, PP: ηp2 = 0.71) and trait (ITT: ηp2 = 0.72, PP: ηp2 = 0.75) anxiety scores clinically for both intention-to-treat and per-protocol analysis. The intervention group had a statistically significant and large decrease in state and trait anxiety scores from pretrial to post-trial. In contrast, the control group had a statistically significant and medium increase in state and trait anxiety scores from pretrial to post-trial. Conclusion The results showed that cognitive-behavioral training reduced the anxiety of pregnant women with positive screening results for chromosomal disorders. According to the results, it is recommended to hold cognitive-behavioral training classes to reduce the anxiety of pregnant women with a positive screening result for chromosomal disorders. Trial registration IRCT.ir: IRCT20180427039436N7; date of registration: 24/08/2020 2020-08-24.

Peri-Implant Tissue Behaviour Next to Different Titanium Surfaces: 16-Year Post-Trial Follow-Up

The present post-trial follow-up investigated the influence of titanium implants with different surface treatments on clinical behavior of soft and hard peri-implant tissues. Each of the 18 included patients received at least two adjacent implants: one control implant with a dual acid-etched (DAE) surface in their apical portion and a machined coronal part, and one test implant with a DAE surface up to its coronal portion. Peri-implant bone level change (BLC), probing depth (PD), bleeding on probing (BOP) and plaque index (PI) were recorded. A total of 42 implants was inserted. The mean follow-up period was 9.3 years (range: 5–16 years) and there were six dropouts. No implant failed. Moderate crestal bone remodeling occurred during the first year after implant insertion, with lower bone loss next to test implants compared to control ones (0.80 vs. 1.39 mm; p = 0.002). This difference was also detected at the 5- (p = 0.011), 6- (p = 0.008) and 7-year follow-up appointment (p = 0.027). No statistically significant differences were found in bone resorption between implants rehabilitated with ceramic vs. composite resin veneering material. No statistically significant differences were detected between test and control implants for BOP, PI, and PD at any time point. The results of the present study suggest that DAE surfaces reduce peri-implant bone loss in the initial phase of healing compared to machined surfaces, while they do not significantly affect soft peri-implant tissue and bone maintenance in the long-term. In conclusion, the minimally rough surfaces favour peri-implant bone maintenance and their effect is greater in the first year post implant insertion.